MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS PAT RESRF RD 41 MM STD; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CEMENTD,POLYMR/METAL/POLYMR

Catalog Number	74024841
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	04/14/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient was stepping backwards down a step and heard a "popping" sensation and immediate pain.Revision surgery was done due to patellar fracture and loosening of patellar component with revision of patellar component and tibial insert.
Additional Manufacturer Narrative
Corrections based on additional information received.
Additional Manufacturer Narrative
Corrections based on received information.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please see attached for the results of our investigation.

• Brand Name: JRNY BCS PAT RESRF RD 41 MM STD
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CEMENTD,POLYMR/METAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6838196
• Report Number: 1020279-2017-00692
• Device Sequence Number: 10780158
• Product Code: JWH
• UDI-Device Identifier: 03596010554550
• UDI-Public: 03596010554550
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional,other,stu
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/02/2023
• Device Catalogue Number: 74024841
• Device Lot Number: 13CM01955
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2017
• Supplement Date Received by Manufacturer: 08/07/2017; 09/01/2017; 09/01/2017; 09/01/2017
• Initial Report FDA Received Date: 09/01/2017
• Supplement Report FDA Received Date: 09/04/2017; 09/14/2017; 10/30/2017; 11/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: JOURNEY TIBIA BASE NP RT SZ 7, 74022217 / UNK LOT; JRNY BCS II FEMORAL OXIN RT SZ 7, 74022117/UNK LOT; JRNYIIBCS XLPE ISRT SZ7-8RT11MM, 74027273/UNK LOT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 108